Binimetinib and Encorafenib for the Treatment of Metastatic Melanoma and Central Nervous System Metastases

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

This phase II trial studies the effects of binimetinib and encorafenib in treating patients with melanoma that has spread to the central nervous system (metastases). Binimetinib and encorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving binimetinib and encorafenib may help control melanoma that has spread to the brain.

Eligibility criteria

Qualifiers

Able to provide written informed consent.

Age >= 18 years at the time of informed consent

Histologically confirmed diagnosis of melanoma

Presence of BRAFV600 mutation in tumor tissue previously determined by a local assay (including immunohistochemistry [IHC]) at any time prior to Screening or during Screening

Disqualifiers

Evidence of active infection =< 7 days prior to initiation of study drug therapy (does not apply to viral infections that are presumed to be associated with the underlying tumor type required for study entry)

Use of non-oncology vaccines containing live virus for prevention of infectious diseases within 30 days of prior to study drug. Dead virus vaccines (e.g Flu) are allowed, even during treatment with study drug

Inability to swallow and retain study treatment

Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) even if fully immunocompetent on antiretroviral therapy (ART)

Trial design

Treatments tested in this trial

  • Binimetinib
  • Encorafenib
  • Questionnaire Administration

Treatment groups

35 Participants
are divided into 1 treatment group

Sponsors and collaborators